| CTRI Number |
CTRI/2024/03/064116 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) [prospective,rendomized,open label,clinical trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of pain relieving efficacy in transverse abdominal plane block and erector spinae plane block in a patient posted following pcnl under general anaesthesia |
|
Scientific Title of Study
|
Ultrasound guided subcostal transversus abdominal plane (TAP) block versus erector spinae plane (ESP) block for post operative analgesia following per cutaneous nephrolithotomy under general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Baldaniya |
| Designation |
Resident |
| Affiliation |
Mahatma Gandhi Hospital and Medical College |
| Address |
OT complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7984461253 |
| Fax |
|
| Email |
vijaybaldaniya1820@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Sachdev |
| Designation |
vice chancellor(Mgumst) and professor of Anesthesia |
| Affiliation |
Mahatma Gandhi Hospital and Medical College |
| Address |
OT complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur, Rajasthan
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829055666 |
| Fax |
|
| Email |
drsudhirmgmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Sachdev |
| Designation |
vice chancellor(Mgumst) and professor of Anesthesia |
| Affiliation |
Mahatma Gandhi Hospital and Medical College |
| Address |
OT complex 2nd floor Department of Anesthesia Mahatma Gandhi Medical College And Hospital,Sitapura,Jaipur, Rajasthan
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829055666 |
| Fax |
|
| Email |
drsudhirmgmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College And Hospital, Sitapura industrial area, Jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College And Hospital |
| Address |
Department of Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura,Jaipur,Rajasthan |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay baldaniya |
Mahatma Gandhi Hospital and Medical College |
OT complex 2nd floor Department of Anesthesia Mahatma Gandhi hospital Sitapura jaipur
Jaipur
RAJASTHAN |
7984461253
vijaybaldaniya1820@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethies Committee Mahatma Gandhi Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ultrasound guided subcostal TAP block in one group of patients and ESP in another group for post oprative analgesia following PCNL under GA. |
patients planned for PCNL surgery will be included in this study.
A total of 60 patients would be randomly divided into two groups of 30 each with the help of a chit box method.
General anaesthesia will be administered with i.v. fentanyl 2mcg/kg, propofol 2 mg/kg, andparalyzed with atracurium 0.5 mg/kg.
Patient will be intubated And
Patient will be positioned prone for the surgery with appropriate padding.
At the end of the surgery, a SUBCOSTAL transverse abdominis plane block will be given in supine position for participants of Group A and, Group B participants will receive ESP Block and both using bupivacaine 0.25% 25 ml at T10 level by the principal investigator in prone position itself.
The transverse processes of the vertebrae at the level of surgery, the erector spinae muscle will be identified.
The ultrasound machine will be placed on the opposite side of the back of the patient that has to be blocked. Under all aseptic precautions, 21G needle will be inserted parallel to the USG beam at an angle of 30-45 degrees in craniocaudal direction, until bone contact with the top of the transverse process is reached. After slight retraction; thereafter, a total of 0.25% bupivacaine 25 ml will be injected. The spread of drug will be observed ultrasonographically.
Then the patient will be turned supine and extubated |
| Comparator Agent |
Comparison of USG guided TAP block and ESP block in post operative analgesia |
Subjects are given different blocks at the end of surgery that implement a multi-modal approach to managing pain. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for PCNL surgery.
Patients of either sex having age 18-65years.
Patients who are willing to participate in this study by written and informed consent.
Patient fulfilling criteria of American Society of Anesthesiology (ASA) of Classes I/ II. |
|
| ExclusionCriteria |
| Details |
Patients with ASA physical status grade III/IV
Patients with history of drug allergy
Infection at local site
H/o drug abuse, psychiatric disorder, chronic pain
coagulation abnormalities |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the analgesic effect of subcostal transversus abdominal plane block and erector spine block will be assessed at the end of operation by haemodynamic variability and postoperatively by visual analog scale(VAS), if VAS is more than 4 the patient will receive a rescue dose of 1mg/kg/dose of tramadol. |
VAS scores will be assessed at intervals of 30 min, 60 min, 2nd hour, 4th hour and then followed fourhourly(8, 12, 16, 20, 24) up to 24 hour postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mean blood pressure, heart rate, patient satisfaction |
The effects will be assessed for 24 hrs post procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
22/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
post operative pain management is an essential component of anaesthetic management of surgical patient. it ensure patient comfort, fewer cardiac and respiratory complication, early mobilization and hence less chances of deep vein thrombosis. the goal of postoperative pain management is to relieve pain while keeping side effects to a minimum. Even after years of advances, the mainstay of pain therapy is still the opioids. while they are very effective analgesics, opioid also carry with them many undesirable side effects: sedation, respiratory depression, nausea and vomiting, hypotension and and bradycardia, pruritis and inhibition of bowel function. to avoid these newer modalities of pain management are being evaluated. The erector spinae plane (ESP) block is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. it was first described as analgesic therapy for chest neuropathic pain in 2016 .TAP block is most often used to provide surgical anaesthesia for minor superficial procedures on the lower abdominal wall, or post-operative analgesia for processor’s below the umbilicus. It has been proven to be effective for the reduction of postoperative pain intensity after lower abdominal surgery under the umbilicus, especially within 24 h after surgery. |